Executive Director, Quality Assurance, Europe

☞ Ultragenyx Pharmaceutical

View: 186

Update day: 29-03-2024

Location: Allschwil Basel-Landschaft BL

Category: Pharmaceutical / Chemical / Biotech Legal / Contracts

Industry:

Job type: Temps plein, Temps de travail : 90-100%

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Job content

Why Join Us?
Be a hero for our rare disease patients
At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.
Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.
If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team. During the COVID-19 Outbreak, we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our approach will include video discussions, interviews, and onboarding.

US based roles: starting on January 3rd, 2022, full vaccination against COVID-19 is a condition of employment at Ultragenyx. This requirement applies to almost all roles at Ultragenyx based in the U.S., with very limited exceptions. If you are unable to receive a COVID-19 vaccine due to a disability, serious medical condition, or because it would violate your sincerely held religious belief, you will have an opportunity to request a reasonable accommodation.

Position summary
ultradedicated –Your biggest challenges yield rare possibilities

As Executive Director, Quality Assurance, you maintain strategic and operational responsibility for European QA Operations. In this role, you develop and manage a scalable and proactive Quality Assurance organization, and anticipate and plan for future needs in the European region to support the Ultragenyx business. Additionally, you obtain and maintain the required licenses in the EU to support product launches and commercial activities in Europe and Mexico. You collaborate with CMC QA teams and manage QP declarations and product release in the region Europe. You manage performance and development of your direct reports to achieve organizational and department goals in an engaging and productive environment. In this role, you report to the SVP, Quality Assurance.

What you will be doing

    • Develop, and lead the Quality Assurance team that manages batch disposition and health authority communications for quality matters in the EU.
    • Partner with Quality Compliance, CMC QA, QC, Technical Operations, Regulatory Affairs, Commercial and Supply chain organizations to ensure uninterrupted, safe, and efficatious product supply that meets patient and regulator expectations.
    • Deploy resources to develop, negotiate, and manage quality agreements. Ensure effective execution of Quality Technical Agreements.
    • Implement and maintain the Ultragenyx Quality System in EU
    • Represent Ultragenyx during inspections and/or discussions with health authorities.
    • Manage QP/RP responsibilities including:
    • Qualified Person (QP) in the European Economic Area (EEA) in the Netherlands for Ultragenyx Netherlands B.V.
    • Responsible Person (RP) in Switzerland for Ultragenyx Europe GmbH
    • Responsible Person (GDP-RP) in the Netherlands and Germany.
    • Ensure development of quality metrics that predict the performance and health of the quality systems and processes.
    • Ensure completeness of technical evaluation and quality due diligence activities as required.
    • Collaborate with CMC Leads and Portfolio Management partners to ensure successful planning, execution and delivery of projects.
    • Ensure activities and deliverables are in compliance with FDA, EMA and local regulations and guidance, ICH guidelines, Ultragenyx policies, SOPs and industry best practices.
    • Participate in external collaborations to influence policy, practices and current guidance for the manufacture of biologics, small molecules and novel therapeutics.

What you bring to the role

    • Registered as QP or Swiss Responsible Person or ability to fulfill legal requirements (education, knowledge, experience) to get registered as EU QP or Swiss RP. Experience managing quality decisions and release decisions for commercial and clinical products.
    • Ideal candidate has experience across several modalities including small molecule, biologic, and advanced therapeutic (gene therapy, mRNA) products.
    • Master’s degree or equivalent in a scientific discipline (Pharmacy, Biology, Chemistry, Biochemistry) required.
    • +15 years experience in pharmaceutical / medical device industry.
    • Minimum of 10 years of experience in a Quality Organization in a CBER/CDER regulated industry.
    • +10 years experience leading and developing teams.
    • Experience in product lifecycle management.
    • Demonstrate quality mindset and ability to effectively collaborate and influence across the entire organization.
    • Ability to manage budget and resourcing and to lead a department.
    • Expert knowledge of cGMPs, with a focus on knowledge of Swiss and EU laws and ordinances.
    • Knowledge and experience negotiating quality agreements and managing vendor relationships and performance.
    • Strong interpersonal skills and the ability to work well as part of a team.
    • Exceptional verbal and written communication skills.
    • Proficient in risk assessment and root cause analysis tools.
    • Ingenuity to develop quality processes that fit virtual DS and DP product manufacturing operations for biologics, small molecules and novel therapeutics.
    • Experience with pre-clinical, clinical and commercial product and phase appropriate application of quality systems and requirements
    • Ability to travel to vendor sites as well as work on site at Ultragenyx offices in Switzerland, Germany, and Netherlands as required and as COVID regulations allow.
    • Ability to travel (10%) to Ultragenyx offices outside the EU region as COVID regulations allow.
Eligible applicants are in possession of a valid work permit for Switzerland.

#LI-DNI

Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by calling: (415) 483-8800 or by emailing us attalentacquisition@ultragenyx.com. For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information.
See ourCCPA Employee and Applicant Privacy Notice.
See ourPrivacy Policy.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to:talentacquisition@ultragenyx.com.
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Deadline: 13-05-2024

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